niCARdipine Hydrochloride Injection — Class II drug recall D-0503-2024
Terminated recall by American Regent, Inc., reported 2024-05-29, distributed in UT. Lack of Assurance of Sterility.
| Recall number | D-0503-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Regent, Inc., New Albany, OH, United States |
| Recall initiated | 2024-05-14 |
| Classified | 2024-05-21 |
| Reported by FDA | 2024-05-29 |
| Terminated | 2025-12-23 |
| Distributed | UT |
| Reason classes | sterility |
| NDC | 72572-0470, 72572-0470-01, 72572-0470-10 |
| Lot numbers | 23087N0C0 |
| Expiration dates | 2024-11 |
Product
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10
Reason for recall
Lack of Assurance of Sterility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0503-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.